Cryogenic Blunt Dissection Methods and Devices

ABSTRACT

A point of incision is created within tissue, the tissue having a temporoparietal fascia-deep temporoparietal fascia layer (TPF-sDTF) beneath skin and a temporal branch of a target nerve extending along a portion of the TPF-sDTF, the point of incision being laterally displaced from the target nerve. A cryogenic probe having a distal tip extending from an elongated body is inserted into the point of incision. The TPF-sDTF is bluntly dissected using the cryogenic probe such that a treating portion of the cryogenic probe is directly adjacent to a first treatment portion of the target nerve. The cryogenic probe is activated to create a first treatment zone at the first treatment portion of the target nerve to cause a therapeutic effect.

CROSS REFERENCES TO RELATED APPLICATIONS

The present application is a Continuation of U.S. patent application No.15/893,178 filed Feb. 9, 2018 (Allowed); which is a Continuation of U.S.patent application No. 14/218,886 filed Mar. 18, 2014; which claims thebenefit of U.S. Provisional Appln No. 61/801,268 on Mar. 15, 2013; thedisclosures of which are incorporated herein by reference in theirentirety for all purposes.

BACKGROUND OF THE INVENTION

The present invention is generally directed to medical devices, systems,and methods, particularly for cooling-induced remodeling of tissues.Embodiments of the invention include devices, systems, and methods forapplying cryogenic cooling to dermatological tissues so as toselectively remodel one or more target tissues along and/or below anexposed surface of the skin. Embodiments may be employed for a varietyof cosmetic conditions, optionally by inhibiting undesirable and/orunsightly effects on the skin (such as lines, wrinkles, or cellulitedimples) or on other surrounding tissue. Other embodiments may find usefor a wide range of medical indications, for example, such as painmanagement, movement disorders, surgical methods, and aesthetictreatments. Such embodiments can include the treatment of peripheralnerves positioned within a fascia, such as sensory and motor nerves Theremodeling of the target tissue may achieve a desired change in itsbehavior or composition.

Therapeutic treatment of chronic or acute pain is among the most commonreasons patients seek medical care. Chronic pain may be particularlydisabling, and the cumulative economic impact of chronic pain is huge. Alarge portion of the population that is over the age of 65 may sufferfrom any of a variety of health issues which can predispose them tochronic or acute pain. An even greater portion of the nursing homepopulation may suffer from chronic pain.

Current treatments for chronic pain may include pharmaceuticalanalgesics and electrical neurostimulation. While both these techniquesmay provide some level of relief, they can have significant drawbacks.For example, pharmaceuticals may have a wide range of systemic sideeffects, including gastrointestinal bleeding, interactions with otherdrugs, and the like. Opiod analgesics can be addictive, and may also ofthemselves be debilitating. The analgesic effects provided bypharmaceuticals may be relatively transient, making themcost-prohibitive for the aging population that suffers from chronicpain. While neurostimulators may be useful for specific applications,they generally involve surgical implantation, an expensive which carriesits own risks, side effects, contraindications, on-going maintenanceissues, and the like.

Chemodenervation and Neurolysis are other techniques for treating painin which a nerve is damaged so that it can no longer transmit signals.The use of neurotoxins (such as botulinum toxin or BOTOX®) forChemodenervation has received some support. Unfortunately, significantvolumes of toxins may be used on a regular basis for effectiveChemodenervation, and such use of toxins can have significantdisadvantages. Neurolysis techniques may involve injections of phenol orethyl alcohol or the use of energy to cause a thermal injury to thenerves such as via the application of radiofrequency (“RF”) energy toachieve ablation, or the like. While several of these alternativeneurolysis approaches may avoid systemic effects and/or prevent damage,additional improvements to neurolysis techniques would be desirable.

The desire to reshape various features of the human body to eithercorrect a deformity or merely to enhance one's appearance is common.This is evidenced by the growing volume of cosmetic surgery proceduresthat are performed annually.

Many procedures are intended to change the surface appearance of theskin by reducing lines and wrinkles. Some of these procedures involveinjecting fillers or stimulating collagen production. More recently,pharmacologically based therapies for wrinkle alleviation and othercosmetic applications have gained in popularity.

Botulinum toxin type A (BOTOX®) is an example of a pharmacologicallybased therapy used for cosmetic applications. It is typically injectedinto the facial muscles to block muscle contraction, resulting intemporary enervation or paralysis of the muscle. Once the muscle isdisabled, the movement contributing to the formation of the undesirablewrinkle is temporarily eliminated. Another example of pharmaceuticalcosmetic treatment is mesotherapy, where a cocktail of homeopathicmedication, vitamins, and/or drugs approved for other indications isinjected into the skin to deliver healing or corrective treatment to aspecific area of the body. Various cocktails are intended to effect bodysculpting and cellulite reduction by dissolving adipose tissue, or skinresurfacing via collagen enhancement. Development ofnon-pharmacologically based cosmetic treatments also continues. Forexample, endermology is a mechanical based therapy that utilizes vacuumsuction to stretch or loosen fibrous connective tissues which areimplicated in the dimpled appearance of cellulite.

While BOTOX® and/or mesotherapies may temporarily reduce lines andwrinkles, reduce fat, or provide other cosmetic benefits they are notwithout their drawbacks, particularly the dangers associated withinjection of a known toxic substance into a patient, the potentialdangers of injecting unknown and/or untested cocktails, and the like.Additionally, while the effects of endermology are not known to bepotentially dangerous, they are brief and only mildly effective.

In light of the above, improved medical devices, systems, and methodsutilizing a cryogenic approach to treating the tissue have beenproposed, particularly for treatment of wrinkles, fat, cellulite, andother cosmetic defects. These new techniques can provide an alternativevisual appearance improvement mechanism which may replace and/orcompliment known bioactive and other cosmetic therapies, ideallyallowing patients to decrease or eliminate the injection of toxins andharmful cocktails while providing similar or improved cosmetic results.These new techniques are also promising because they may be performedpercutaneously using only local or no anesthetic with minimal or nocutting of the skin, no need for suturing or other closure methods, noextensive bandaging, and limited or no bruising or other factorscontributing to extended recovery or patient “down time.” Additionally,cryogenic treatments are also desirable since they may be used in thetreatment of other cosmetic and/or dermatological conditions (andpotentially other target tissues), particularly where the treatments maybe provided with greater accuracy and control, less collateral tissueinjury and/or pain, and greater ease of use.

While these new cryogenic treatments are promising, careful control oftemperature along the cryogenic probe is necessary in order to obtaindesired results in the target treatment area as well as to avoidunwanted tissue injury (tissue blackening) in adjacent areas. Further,there are challenges associated accuracy in finding the appropriatedepth of target tissue. Thus, it is desirable to implement devices andmethods to mitigate such issues. Further, it would be advantageous toprovide improved devices, systems, and methods for management of chronicand/or acute pain. Such improved techniques may avoid or decrease thesystemic effects of toxin-based neurolysis and pharmaceuticalapproaches, while decreasing the invasiveness and/or collateral tissuedamage of at least some known pain treatment techniques.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the invention are related to blunt dissection devices forlaterally traversing a layer beneath skin from an incision point andtreating a portion of tissue laterally displaced from the incisionpoint.

Embodiments of the invention relate to certain methods. For manymethods, a point of incision is created within tissue. The tissueincludes skin, a layer of soft tissue and a layer of resilient tissue. Acryogenic probe having a distal tip extending from an elongated body isinserted into the point of incision. The soft tissue is bluntlydissected using the cryogenic probe such that a treating portion of thecryogenic probe is directly adjacent to the resilient layer. Thecryogenic probe is then advanced along the resilient layer. Thecryogenic probe is then repeatedly moving and activating the treatingportion of such that a plurality of treatment zones is created across anerve adjacent to the resilient layer.

In many embodiments, the soft tissue layer is comprised of adiposetissue, muscle, and/or subcutaneous tissue.

In many embodiments, the layer of resilient tissue is a fascia layer.

In many embodiments, the layer of resilient tissue is cartilage,periosteum, or bone.

For many methods, a point of incision is created within tissue, thetissue comprising a temporoparietal fascia-deep temporoparietal fascialayer (TPF-sDTF) beneath skin and a temporal branch of a facial nerve(TB-FN) extending along a portion of the TPF-sDTF. The point of incisionis laterally displaced from the TB-FN. A cryogenic probe having a distaltip extending from an elongated body is then inserted into the point ofincision. The TPF-sDTF is then bluntly dissected using the cryogenicprobe such that a treating portion of the cryogenic probe is directlyadjacent to a first treatment portion of the TB-FN. The cryogenic probecan be activated to create a cooling treatment zone at the treatmentportion of the TB-FN and thus cause a therapeutic effect. Alternatively,the cryogenic probe can also be repeatedly moved and activated at thetreating portion of the cryogenic probe such that a plurality oftreatment zones is created across the TB-FN.

In many embodiments, the elongated body is placed such that it traversesacross the first treatment portion of the TB-FN.

In many embodiments, the cooling treatment zone emanates from a distinctportion of the elongated body.

In many embodiments, the distal tip is placed such that it is located atthe first treatment portion of the TB-FN.

In many embodiments, the cooling treatment zone emanates from the distaltip.

In many embodiments, methods include relocating the treating portion ofthe cryogenic probe to a second treatment portion of the TB-FN, andactivating the cryogenic probe to create a second cooling treatment zoneat the second treatment portion of the TB-FN to further the therapeuticeffect.

In many embodiments, the second treatment zone is adjacent to the firsttreatment zone.

In many embodiments, the second treatment zone overlaps with the firsttreatment zone.

In many embodiments, the first treatment portion is directly beneath avisible area of the skin, and wherein the incision is directly beneath aportion of scalp covered by hair.

Embodiments of the invention relate to certain devices. Such devices caninclude a cryogenic probe having a distal tip extending from anelongated body adapted to laterally traverse a temporoparietalfascia-deep temporoparietal fascia layer (TPF-sDTF) beneath skin to atemporal branch of a facial nerve (TB-FN) extending along a portion ofthe TPF-sDTF from a point of incision being laterally displaced from theTB-FN. The distal tip can be adapted to bluntly dissect the TPF-sDTFsuch that a treating portion of the cryogenic probe is directly adjacentto a first treatment portion of the TB-FN. The elongated body houses afluid path for creating a cooling treatment zone at the treatmentportion of the TB-FN to cause a therapeutic effect. However, use ofthese devices are not limited to the TPF-sDTF, since in manyembodiments, such devices can be used to traverse along a tissueinterface or fascia conforming to the interface plane by bluntdissection along the interface in order to position the treatment tip ina desired tissue plane. For any target peripheral nerve, there exist atleast one tissue interface or fascia layer that can be used as aninternal body surface for deflecting the flexible blunt tip device so itadheres to the internal body surface for preferred placement. Forexample, if the target nerve has a fascia layer immediately below it,then this fascia is an ideal candidate for deflecting the flexible blunttip device into treatment position because it will help guide thetreatment portion of the blunt tip device into position adjacent to thetarget nerve.

Embodiments of the invention relate to systems having a probe body, anelongated probe extending from the probe body and having a blunt distaltip. A cryogen supply tube extends within the elongated probe. Theelongated probe and supply tube are configured to resiliently bend. Forexample, resiliently bend such that the blunt distal tip glides alongthe sDTF while dissecting the TPF.

In many embodiments, the elongated probe is 15 gauge or smaller indiameter.

In many embodiments, the elongated probe is 20-30 mm in diameter.

In many embodiments, the elongated probe is over 30 mm in length.

In many embodiments, the elongated probe is 30-150 mm in length.

In many embodiments, a first portion of the elongated probe and cryogensupply tube are configured to resiliently bend at an angle up to 120°.In further embodiments, a second portion of the elongated probe andcryogen supply tube are configured to resiliently bend to a lesserdegree than the first portion.

In many embodiments, a coolant supply source coupled to the supply tube.

In many embodiments, the supply tube comprises a fused silica tubehaving a reinforcement portion.

In many embodiments, the flexibility of the elongated probe can varyfrom one end to the other end in a continuous or discrete segments. Theadvantage of this is to allow the leading portion of the elongated probeto be less flexible so insertion force can be translated to the tip moreeffectively. When the tip encounters resistance and a lateral force, itis the portion of the needle to bend adhering to this lateral forcewhile the proximal portion of the elongated probe deflects less.

In many embodiments, the system includes a cannula curved to assist indirecting the elongated probe into a desired tissue layer coincidentwith predetermined pathway.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a self-contained subdermal cryogenicremodeling probe and system, according to an embodiment of theinvention.

FIG. 1B is a partially transparent perspective view of theself-contained probe of FIG. 1A, showing internal components of thecryogenic remodeling system and schematically illustrating replacementtreatment needles for use with the disposable probe, according to anembodiment of the invention.

FIG. 2 schematically illustrates components that may be included in thetreatment system, according to an embodiment of the invention.

FIGS. 3A-3D illustrate exemplary embodiments of a needle probe,according to embodiments of the invention.

FIGS. 4A-4C illustrate an exemplary method of introducing a cryogenicprobe to a treatment area, according to embodiments of the invention.

FIG. 4D illustrates an alternative embodiment of a sheath, according toan embodiment of the invention.

FIG. 5 illustrates an insulated cryoprobe, according to an embodiment ofthe invention.

FIGS. 6-9 illustrate exemplary embodiments of cryofluid delivery tubes,according to embodiments of the invention.

FIG. 10 illustrates an example of blunt tipped cryoprobe, according toan embodiment of the invention.

FIGS. 11 and 12 illustrate actuatable cryoprobes, according toembodiments of the invention.

FIGS. 13A-13D illustrate methods for treating tissue, according toembodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides improved medical devices, systems, andmethods. Embodiments of the invention will facilitate remodeling oftarget tissues disposed at and below the skin, optionally to treat acosmetic defect, a lesion, a disease state, and/or so as to alter ashape of the overlying skin surface.

Among the most immediate applications of the present invention may bethe amelioration of lines and wrinkles, particularly by inhibitingmuscular contractions which are associated with these cosmetic defectsso as so improve an appearance of the patient. Rather than relyingentirely on a pharmacological toxin or the like to disable muscles so asto induce temporary paralysis, many embodiments of the invention will atleast in part employ cold to immobilize muscles. Advantageously, nerves,muscles, and associated tissues may be temporarily immobilized usingmoderately cold temperatures of 10° C. to −5° C. without permanentlydisabling the tissue structures. Using an approach similar to thatemployed for identifying structures associated with atrial fibrillation,a needle probe or other treatment device can be used to identify atarget tissue structure in a diagnostic mode with these moderatetemperatures, and the same probe (or a different probe) can also be usedto provide a longer term or permanent treatment, optionally by ablatingthe target tissue zone and/or inducing apoptosis at temperatures fromabout −5° C. to about −50° C. In some embodiments, apoptosis may beinduced using treatment temperatures from about −1° C. to about −15° C.,or from about −1° C. to about −19° C., optionally so as to provide apermanent treatment that limits or avoids inflammation and mobilizationof skeletal muscle satellite repair cells. In some embodiments,temporary axonotmesis degeneration of a motor nerve is desired, whichmay be induced using treatment temperatures from about −20° C. to about−100° C. and maybe as low as −140° C. In some embodiments, neurotmesisinjury of a motor nerve is desired, which may be induced using treatmenttemperatures below −140° C. and maybe up to temperatures below −100° C.Hence, the duration of the treatment efficacy of such subdermalcryogenic treatments may be selected and controlled, with coldertemperatures, longer treatment times, and/or larger volumes or selectedpatterns of target tissue determining the longevity of the treatment.Additional description of cryogenic cooling for treatment of cosmeticand other defects may be found in commonly assigned U.S. Pat. No.7,713,266 entitled “Subdermal Cryogenic Remodeling of Muscle, Nerves,Connective Tissue, and/or Adipose Tissue (Fat)”, U.S. Pat. No. 7,850,683entitled “Subdermal Cryogenic Remodeling of Muscles, Nerves, ConnectiveTissue, and/or Adipose Tissue (Fat)”, and U.S. Pat. No. 9,039,688entitled “Method for Reducing Hyperdynamic Facial Wrinkles”, the fulldisclosures which are incorporated herein by reference.

In addition to cosmetic treatments of lines, wrinkles, and the like,embodiments of the invention may also find applications for treatmentsof subdermal adipose tissues, benign, pre-malignant lesions, malignantlesions, acne and a wide range of other dermatological conditions(including dermatological conditions for which cryogenic treatments havebeen proposed and additional dermatological conditions), and the like.Embodiments of the invention may also find applications for alleviationof pain, including those associated with muscle spasms as disclosed incommonly assigned U.S. Pat. No. 8,298,216 entitled “Pain ManagementUsing Cryogenic Remodeling” the full disclosure which is incorporatedherein by reference.

Referring now to FIGS. 1A and 1B, a system for cryogenic remodeling herecomprises a self-contained probe handpiece generally having a proximalend 12 and a distal end 14. A handpiece body or housing 16 has a sizeand ergonomic shape suitable for being grasped and supported in asurgeon's hand or other system operator. As can be seen most clearly inFIG. 1B, a cryogenic cooling fluid supply 18, a supply valve 32 andelectrical power source 20 are found within housing 16, along with acircuit 22 having a processor for controlling cooling applied byself-contained system 10 in response to actuation of an input 24.Alternatively, electrical power can be applied through a cord from aremote power source. Power source 20 also supplies power to heaterelement 44 in order to heat the proximal region of probe 26 therebyhelping to prevent unwanted skin damage, and a temperature sensor 48adjacent the proximal region of probe 26 helps monitor probetemperature. Additional details on the heater 44 and temperature sensor48 are described in greater detail below. When actuated, supply valve 32controls the flow of cryogenic cooling fluid from fluid supply 18. Someembodiments may, at least in part, be manually activated, such asthrough the use of a manual supply valve and/or the like, so thatprocessors, electrical power supplies, and the like may not be required.

Extending distally from distal end 14 of housing 16 is atissue-penetrating cryogenic cooling probe 26. Probe 26 is thermallycoupled to a cooling fluid path extending from cooling fluid source 18,with the exemplary probe comprising a tubular body receiving at least aportion of the cooling fluid from the cooling fluid source therein. Theexemplary probe 26 comprises a 27 g needle having a sharpened distal endthat is axially sealed. Probe 26 may have an axial length between distalend 14 of housing 16 and the distal end of the needle of between about0.5 mm and 5 cm, preferably having a length from about 3 mm to about 10mm. Such needles may comprise a stainless steel tube with an innerdiameter of about 0.006 inches and an outer diameter of about 0.012inches, while alternative probes may comprise structures having outerdiameters (or other lateral cross-sectional dimensions) from about 0.006inches to about 0.100 inches. Generally, needle probe 26 will comprise a16 g or smaller size needle, often comprising a 20 g needle or smaller,typically comprising a 25, 26, 27, 28, 29, or 30 g or smaller needle.

In some embodiments, probe 26 may comprise two or more needles arrangedin a linear array, such as those disclosed in previously incorporatedU.S. Pat. No. 7,850,683. Another exemplary embodiment of a probe havingmultiple needle probe configurations allow the cryogenic treatment to beapplied to a larger or more specific treatment area. Other needleconfigurations that facilitate controlling the depth of needlepenetration and insulated needle embodiments are disclosed in commonlyassigned U.S. Pat. No. 8,409,185 entitled “Replaceable and/or EasilyRemovable Needle Systems for Dermal and Transdermal CryogenicRemodeling,” the entire content which is incorporated herein byreference. Multiple needle arrays may also be arrayed in alternativeconfigurations such as a triangular or square array.

Arrays may be designed to treat a particular region of tissue, or toprovide a uniform treatment within a particular region, or both. In someembodiments needle 26 is releasably coupled with body 16 so that it maybe replaced after use with a sharper needle (as indicated by the dottedline) or with a needle having a different configuration. In exemplaryembodiments, the needle may be threaded into the body, it may be pressfit into an aperture in the body or it may have a quick disconnect suchas a detent mechanism for engaging the needle with the body. A quickdisconnect with a check valve is advantageous since it permitsdecoupling of the needle from the body at any time without excessivecoolant discharge. This can be a useful safety feature in the event thatthe device fails in operation (e.g. valve failure), allowing an operatorto disengage the needle and device from a patient's tissue withoutexposing the patient to coolant as the system depressurizes. Thisfeature is also advantageous because it allows an operator to easilyexchange a dull needle with a sharp needle in the middle of a treatment.One of skill in the art will appreciate that other coupling mechanismsmay be used.

Addressing some of the components within housing 16, the exemplarycooling fluid supply 18 comprises a canister, sometimes referred toherein as a cartridge, containing a liquid under pressure, with theliquid preferably having a boiling temperature of less than 37° C. Whenthe fluid is thermally coupled to the tissue-penetrating probe 26, andthe probe is positioned within the patient so that an outer surface ofthe probe is adjacent to a target tissue, the heat from the targettissue evaporates at least a portion of the liquid and the enthalpy ofvaporization cools the target tissue. A supply valve 32 may be disposedalong the cooling fluid flow path between canister 18 and probe 26, oralong the cooling fluid path after the probe so as to limit coolant flowthereby regulating the temperature, treatment time, rate of temperaturechange, or other cooling characteristics. The valve will often bepowered electrically via power source 20, per the direction of processor22, but may at least in part be manually powered. The exemplary powersource 20 comprises a rechargeable or single-use battery. Additionaldetails about valve 32 are disclosed below and further disclosure on thepower source 20 may be found in commonly assigned PCT Publn No. WO2010/075438 entitled “Integrated Cryosurgical Probe Package with FluidReservoir and Limited Electrical Power Source,” the entire contentswhich is incorporated herein by reference.

The exemplary cooling fluid supply 18 comprises a single-use canister.Advantageously, the canister and cooling fluid therein may be storedand/or used at (or even above) room temperature. The canister may have afrangible seal or may be refillable, with the exemplary canistercontaining liquid nitrous oxide, N₂O. A variety of alternative coolingfluids might also be used, with exemplary cooling fluids includingfluorocarbon refrigerants and/or carbon dioxide. The quantity of coolingfluid contained by canister 18 will typically be sufficient to treat atleast a significant region of a patient, but will often be less thansufficient to treat two or more patients. An exemplary liquid N₂Ocanister might contain, for example, a quantity in a range from about 1gram to about 40 grams of liquid, more preferably from about 1 gram toabout 35 grams of liquid, and even more preferably from about 7 grams toabout 30 grams of liquid.

Processor 22 will typically comprise a programmable electronicmicroprocessor embodying machine readable computer code or programminginstructions for implementing one or more of the treatment methodsdescribed herein. The microprocessor will typically include or becoupled to a memory (such as a non-volatile memory, a flash memory, aread-only memory (“ROM”), a random access memory (“RAM”), or the like)storing the computer code and data to be used thereby, and/or arecording media (including a magnetic recording media such as a harddisk, a floppy disk, or the like; or an optical recording media such asa CD or DVD) may be provided. Suitable interface devices (such asdigital-to-analog or analog-to-digital converters, or the like) andinput/output devices (such as USB or serial I/O ports, wirelesscommunication cards, graphical display cards, and the like) may also beprovided. A wide variety of commercially available or specializedprocessor structures may be used in different embodiments, and suitableprocessors may make use of a wide variety of combinations of hardwareand/or hardware/software combinations. For example, processor 22 may beintegrated on a single processor board and may run a single program ormay make use of a plurality of boards running a number of differentprogram modules in a wide variety of alternative distributed dataprocessing or code architectures.

Referring now to FIG. 2, the flow of cryogenic cooling fluid from fluidsupply 18 is controlled by a supply valve 32. Supply valve 32 maycomprise an electrically actuated solenoid valve, a motor actuated valveor the like operating in response to control signals from controller 22,and/or may comprise a manual valve. Exemplary supply valves may comprisestructures suitable for on/off valve operation, and may provide ventingof the fluid source and/or the cooling fluid path downstream of thevalve when cooling flow is halted so as to limit residual cryogenicfluid vaporization and cooling. Additionally, the valve may be actuatedby the controller in order to modulate coolant flow to provide highrates of cooling in some instances where it is desirable to promotenecrosis of tissue such as in malignant lesions and the like or slowcooling which promotes ice formation between cells rather than withincells when necrosis is not desired. More complex flow modulating valvestructures might also be used in other embodiments. For example, otherapplicable valve embodiments are disclosed in previously incorporatedU.S. Pat. No. 8,409,185.

Still referring to FIG. 2, an optional heater (not illustrated) may beused to heat cooling fluid supply 18 so that heated cooling fluid flowsthrough valve 32 and through a lumen 34 of a cooling fluid supply tube36. Supply tube 36 is, at least in part, disposed within a lumen 38 ofneedle 26, with the supply tube extending distally from a proximal end40 of the needle toward a distal end 42. The exemplary supply tube 36comprises a fused silica tubular structure (not illustrated) having apolymer coating and extending in cantilever into the needle lumen 38.Supply tube 36 may have an inner lumen with an effective inner diameterof less than about 200 μm, the inner diameter often being less thanabout 100 μm, and typically being less than about 40 μm. Exemplaryembodiments of supply tube 36 have inner lumens of between about 15 and50 μm, such as about 30 μm. An outer diameter or size of supply tube 36will typically be less than about 1000 μm, often being less than about800 μm, with exemplary embodiments being between about 60 and 150 μm,such as about 90 μm or 105 μm. The tolerance of the inner lumen diameterof supply tubing 36 will preferably be relatively tight, typically beingabout +/−10 μm or tighter, often being +/−5 μm or tighter, and ideallybeing +/−3 μm or tighter, as the small diameter supply tube may providethe majority of (or even substantially all of) the metering of thecooling fluid flow into needle 26. Previously incorporated U.S. Pat. No.8,409,185 discloses additional details on the needle 26 along withvarious alternative embodiments and principles of operation.

The cooling fluid injected into lumen 38 of needle 26 will typicallycomprise liquid, though some gas may also be injected. At least some ofthe liquid vaporizes within needle 26, and the enthalpy of vaporizationcools the needle and also the surrounding tissue engaged by the needle.An optional heater 44 (illustrated in FIG. 1B) may be used to heat theproximal region of the needle 26 in order to prevent unwanted skindamage in this area, as discussed in greater detail below. Controlling apressure of the gas/liquid mixture within needle 26 substantiallycontrols the temperature within lumen 38, and hence the treatmenttemperature range of the tissue. A relatively simple mechanical pressurerelief valve 46 may be used to control the pressure within the lumen ofthe needle, with the exemplary valve comprising a valve body such as aball bearing, urged against a valve seat by a biasing spring. Anexemplary relief valve is disclosed in U.S. Provisional PatentApplication No. 61/116,050, previously incorporated herein by reference.Thus, the relief valve allows better temperature control in the needle,minimizing transient temperatures. Further details on exhaust volume aredisclosed in previously incorporated U.S. Pat. No. 8,409,185.

The heater 44 may be thermally coupled to a thermally responsive element50, which is supplied with power by the controller 22 and thermallycoupled to a proximal portion of the needle 26. The thermally responsiveelement 50 can be a block constructed from a material of high thermalconductivity and low heat capacity, such as aluminum. A firsttemperature sensor 52 (e.g., thermistor, thermocouple) can also bethermally coupled the thermally responsive element 50 andcommunicatively coupled to the controller 22. A second temperaturesensor 53 can also be positioned near the heater 44, for example, suchthat the first temperature sensor 52 and second temperature sensor 44are placed in different positions within the thermally responsiveelement 50. In some embodiments, the second temperature sensor 53 isplaced closer to a tissue contacting surface than the first temperaturesensor is in order to provide comparative data (e.g., temperaturedifferential) between the sensors. The controller 22 can be configuredto receive temperature information of the thermally responsive element50 via the temperature sensor 52 in order to provide the heater 44 withenough power to maintain the thermally responsive element 50 at aparticular temperature.

The controller 22 can be further configured to monitor power draw fromthe heater 44 in order to characterize tissue type, perform devicediagnostics, and/or provide feedback for a tissue treatment algorithm.This can be advantageous over monitoring temperature alone, since powerdraw from the heater 44 can vary greatly while temperature of thethermally responsive element 50 remains relatively stable. For example,during treatment of target tissue, maintaining the thermally responsiveelement 50 at 40° C. during a cooling cycle may take 1.0 W initially(for a needle <10 mm in length) and is normally expected to climb to 1.5W after 20 seconds, due to the needle 26 drawing in surrounding heat. Anindication that the heater is drawing 2.0 W after 20 seconds to maintain40° C. can indicate that an aspect of the system 10 is malfunctioningand/or that the needle 26 is incorrectly positioned. Correlations withpower draw and correlated device and/or tissue conditions can bedetermined experimentally to determine acceptable treatment powerranges.

In some embodiments, it may be preferable to limit frozen tissue that isnot at the treatment temperature, i.e., to limit the size of a formedcooling zone within tissue. Such cooling zones may be associated with aparticular physical reaction, such as the formation of an ice-ball, orwith a particular temperature profile or temperature volume gradientrequired to therapeutically affect the tissue therein. To achieve this,metering coolant flow could maintain a large thermal gradient at itsoutside edges. This may be particularly advantageous in applications forcreating an array of connected cooling zones (i.e., fence) in atreatment zone, as time would be provided for the treatment zone tofully develop within the fenced in portion of the tissue, while theouter boundaries maintained a relatively large thermal gradient due tothe repeated application and removal of refrigeration power. This couldprovide a mechanism within the body of tissue to thermally regulate thetreatment zone and could provide increased ability to modulate thetreatment zone at a prescribed distance from the surface of the skin. Arelated treatment algorithm could be predefined, or it could be inresponse to feedback from the tissue.

Such feedback could be temperature measurements from the needle 26, orthe temperature of the surface of the skin could be measured. However,in many cases monitoring temperature at the needle 26 is impractical dueto size constraints. To overcome this, operating performance of thesensorless needle 26 can be interpolated by measuring characteristics ofthermally coupled elements, such as the thermally responsive element 50.

Additional methods of monitoring cooling and maintaining an unfrozenportion of the needle include the addition of a heating element and/ormonitoring element into the needle itself. This could consist of a smallthermistor or thermocouple, and a wire that could provide resistiveheat. Other power sources could also be applied such as infrared light,radiofrequency heat, and ultrasound. These systems could also be appliedtogether dependent upon the control of the treatment zone desired.

Alternative methods to inhibit excessively low transient temperatures atthe beginning of a refrigeration cycle might be employed instead of ortogether with the limiting of the exhaust volume. For example, thesupply valve might be cycled on and off, typically by controller 22,with a timing sequence that would limit the cooling fluid flowing sothat only vaporized gas reached the needle lumen (or a sufficientlylimited amount of liquid to avoid excessive dropping of the needle lumentemperature). This cycling might be ended once the exhaust volumepressure was sufficient so that the refrigeration temperature would bewithin desired limits during steady state flow. Analytical models thatmay be used to estimate cooling flows are described in greater detail inpreviously incorporated U.S. Pat. No. 9,254,162.

Referring now to FIG. 2, the flow of cryogenic cooling fluid from fluidsupply 18 is controlled by a supply valve 32. Supply valve 32 maycomprise an electrically actuated solenoid valve, a motor actuated valveor the like operating in response to control signals from controller 22,and/or may comprise a manual valve. Exemplary supply valves may comprisestructures suitable for on/off valve operation, and may provide ventingof the fluid source and/or the cooling fluid path downstream of thevalve when cooling flow is halted so as to limit residual cryogenicfluid vaporization and cooling. Additionally, the valve may be actuatedby the controller in order to modulate coolant flow to provide highrates of cooling in some instances where it is desirable to promotenecrosis of tissue such as in malignant lesions and the like or slowcooling which promotes ice formation between cells rather than withincells when necrosis is not desired. More complex flow modulating valvestructures might also be used in other embodiments. For example, otherapplicable valve embodiments are disclosed in previously incorporatedU.S. Pat. No. 8,409,185.

Still referring to FIG. 2, an optional cooling supply heater (notillustrated) may be used to heat cooling fluid supply 18 so that heatedcooling fluid flows through valve 32 and through a lumen 34 of a coolingfluid supply tube 36. In some embodiments safety mechanism can beincluded so that the cooling supply is not overheated. Examples of suchembodiments are disclosed in commonly assigned PCT Pub. No. WO2010/075438, the entirety of which is herein incorporated by reference.

Supply tube 36 is, at least in part, disposed within a lumen 38 ofneedle 26, with the supply tube extending distally from a proximal end40 of the needle toward a distal end 42. The exemplary supply tube 36comprises a fused silica tubular structure (not illustrated) having apolymer coating and extending in cantilever into the needle lumen 38.Supply tube 36 may have an inner lumen with an effective inner diameterof less than about 200 μm, the inner diameter often being less thanabout 100 μm, and typically being less than about 40 μm. Exemplaryembodiments of supply tube 36 have inner lumens of between about 15 and50 μm, such as about 30 μm. An outer diameter or size of supply tube 36will typically be less than about 1000 μm, often being less than about800 μm, with exemplary embodiments being between about 60 and 150 μm,such as about 90 μm or 105 μm. The tolerance of the inner lumen diameterof supply tubing 36 will preferably be relatively tight, typically beingabout +/−10 μm or tighter, often being +/−5 μm or tighter, and ideallybeing +/−3 μm or tighter, as the small diameter supply tube may providethe majority of (or even substantially all of) the metering of thecooling fluid flow into needle 26. Additional details on various aspectsof needle 26 along with alternative embodiments and principles ofoperation are disclosed in greater detail in U.S. Pat. No. 9,254,162entitled “Dermal and Transdermal Cryogenic Microprobe Systems andMethods,” the entire contents of which are incorporated herein byreference. U.S. Pat. No. 8,409,185, previously incorporated herein byreference, also discloses additional details on the needle 26 along withvarious alternative embodiments and principles of operation.

The cooling fluid injected into lumen 38 of needle 26 will typicallycomprise liquid, though some gas may also be injected. At least some ofthe liquid vaporizes within needle 26, and the enthalpy of vaporizationcools the needle and also the surrounding tissue engaged by the needle.An optional heater 44 (illustrated in FIG. 1B) may be used to heat theproximal region of the needle in order to prevent unwanted skin damagein this area, as discussed in greater detail below. Controlling apressure of the gas/liquid mixture within needle 26 substantiallycontrols the temperature within lumen 38, and hence the treatmenttemperature range of the tissue. A relatively simple mechanical pressurerelief valve 46 may be used to control the pressure within the lumen ofthe needle, with the exemplary valve comprising a valve body such as aball bearing, urged against a valve seat by a biasing spring. Thus, therelief valve allows better temperature control in the needle, minimizingtransient temperatures. Further details on exhaust volume are disclosedin U.S. Pat. No. 8,409,185, previously incorporated herein by reference.

Alternative methods to inhibit excessively low transient temperatures atthe beginning of a refrigeration cycle might be employed instead of ortogether with the limiting of the exhaust volume. For example, thesupply valve might be cycled on and off, typically by controller 22,with a timing sequence that would limit the cooling fluid flowing sothat only vaporized gas reached the needle lumen (or a sufficientlylimited amount of liquid to avoid excessive dropping of the needle lumentemperature). This cycling might be ended once the exhaust volumepressure was sufficient so that the refrigeration temperature would bewithin desired limits during steady state flow. Analytical models thatmay be used to estimate cooling flows are described in greater detail inU.S. Pat. No. 9,254,162, previously incorporated herein by reference.

In the exemplary embodiment of FIG. 3A, probe tip 300 includes aresistive heater element 314 is disposed near the needle hub 318 andnear a proximal region of needle shaft 302. In other embodiments, theheater may float, thereby ensuring proper skin contact and proper heattransfer to the skin. Examples of floating heaters are disclosed incommonly assigned PCT Pub. No. WO 2010/075448 entitled “Skin Protectionfor Subdermal Cryogenic Remodeling for Cosmetic and Other Treatments,”the entirety of which is incorporated by reference herein.

In this exemplary embodiment, three needles are illustrated. One ofskill in the art will appreciate that a single needle may be used, aswell as two, four, five, six, or more needles may be used. When aplurality of needles are used, they may be arranged in any number ofpatterns. For example, a single linear array may be used, or a twodimensional or three dimensional array may be used. Examples of twodimensional arrays include any number of rows and columns of needles(e.g. a rectangular array, a square array, elliptical, circular,triangular, etc.), and examples of three dimensional arrays includethose where the needle tips are at different distances from the probehub, such as in an inverted pyramid shape.

A cladding 320 of conductive material is directly conductively coupledto the proximal portion of the shaft of needle shaft 302, which can bestainless steel. In some embodiments, the cladding 320 is a layer ofgold, or alloys thereof, coated on the exterior of the proximal portionof the needle shaft 302. In some embodiments, the exposed length ofcladding 320 on the proximal portion of the needle is 2-100 mm. In someembodiments, the cladding 320 can be of a thickness such that the cladportion has a diameter ranging from 0.017-0.020 in., and in someembodiments 0.0182 in. Accordingly, the cladding 320 can be conductivelycoupled to the material of the needle 302, which can be less conductive,than the cladding 320. The cladding 320 may modify the lateral forcerequired to deflect or bend the needle 26. Cladding 320 may be used toprovide a stiffer needle shaft along the proximal end in order to moreeasily transfer force to the leading tip during placement and allow thedistal portion of the needle to deflect more easily when it isdissecting a tissue interface within the body. The stiffness of needle26 can vary from one end to the other end by other means such asmaterial selection, metal tempering, variation of the inner diameter ofthe needle 26, or segments of needle shaft joined together end-to-end toform one contiguous needle 26. In some embodiments, increasing thestiffness of the distal portion of the needle 26 can be used to flex theproximal portion of the needle to access difficult treatment sites as inthe case of upper limb spasticity where bending of the needle outsidethe body may be used to access a target peripheral nerve along thedesired tissue plane.

In some embodiments, the cladding 320 can include sub-coatings (e.g.,nickel) that promote adhesion of an outer coating that would otherwisenot bond well to the needle shaft 302. Other highly conductive materialscan be used as well, such as copper, silver, aluminum, and alloysthereof. In some embodiments, a protective polymer or metal coating cancover the cladding to promote biocompatibility of an otherwisenon-biocompatible but highly conductive cladding material. Such abiocompatible coating however, would be applied to not disruptconductivity between the conductive block 315. In some embodiments, aninsulating layer, such as a ceramic material, is coated over thecladding 320, which remains conductively coupled to the needle shaft302.

In use, the cladding 320 can transfer heat to the proximal portion ofthe needle 302 to prevent directly surrounding tissue from dropping tocryogenic temperatures. Protection can be derived from heating thenon-targeting tissue during a cooling procedure, and in some embodimentsbefore the procedure as well. The mechanism of protection may beproviding heat to pressurized cryogenic cooling fluid passing within theproximal portion of the needle to affect complete vaporization of thefluid. Thus, the non-target tissue in contact with the proximal portionof the needle shaft 302 does not need to supply heat, as opposed totarget tissue in contact with the distal region of the needle shaft 302.To help further this effect, in some embodiments the cladding 320 iscoating within the interior of the distal portion of the needle, with orwithout an exterior cladding. To additionally help further this effect,in some embodiments, the distal portion of the needle can be thermallyisolated from the proximal portion by a junction, such as a ceramicjunction. While in some further embodiments, the entirety of theproximal portion is constructed from a more conductive material than thedistal portion.

In use, it has been determined experimentally that the cladding 320 canhelp limit formation of a cooling zone to the distal portion of theneedle shaft 302, which tends to demarcate at a distal end of thecladding 320. Accordingly, cooling zones are formed only about thedistal portions of the needles—in this case to target a particularsensory nerve branch. Thus, while non-target tissue in direct contactwith proximal needle shafts remain protected from effects of cryogenictemperatures. Such effects can include discoloration and blistering ofthe skin. Such cooling zones may be associated with a particularphysical reaction, such as the formation of an ice-ball, or with aparticular temperature required to therapeutically affect the tissuetherein.

FIGS. 3C and 3D illustrate a detachable probe tip 322 having a hubconnector 324 and an elongated probe 326. The probe tip 322 shares muchof its construction with probe tip 300. However, the elongated probe 326features a blunt tip 328 that is adapted for blunt dissection of tissue.The blunt tip 328 can feature a full radius tip, less than a full radiustip, or conical tip. In some embodiments, a dulled or truncated needleis used. The elongated probe 326 can be greater than 20 gauge in size,and in some embodiments range in size from 25-30 gauge. As with theembodiments described above, an internal supply tube 330 extends incantilever. However, the exit of the supply tube 330 can be disposed atpositions within the elongated probe 326 other than proximate the blunttip 328. Further, the supply tube 330 can be adapted to create anelongated zone of cooling, e.g., by having multiple exit points forcryofluid to exit from.

The elongated probe 326 and supply tube 330 are configured toresiliently bend in use, throughout their length at angles approaching120°, with a 5-10 mm bend radius. This is very challenging consideringthe small sizes of the elongated probe 326 and supply tube 330, and alsoconsidering that the supply tube 330 is often constructed from fusedsilica. Accordingly, the elongated probe 326 can be constructed from aresilient material, such as stainless steel, and of a particulardiameter and wall thickness [0.004 to 1.0 mm], such that the elongatedprobe in combination with the supply tube 330 is not overly resilient soas to overtly resist manipulation, but sufficiently strong so as toprevent kinking that can result in coolant escaping. For example, theelongated probe can be 15 gauge or smaller in diameter, even rangingfrom 20-30 gauge in diameter. The elongated probe can have a verydisparate length to diameter ratio, for example, the elongated probe canbe greater than 30 in length, and in some cases range from 30-100 mm inlength. To further the aforementioned goals, the supply tube 330 caninclude a polymer coating 332, such as a polyimide coating thatterminates approximately halfway down its length, to resist kinking andaid in resiliency. The polymer coating 332 can be a secondary coatingover a primary polyimide coating that extends fully along the supplytube. However, it should be understood that the coating is not limitedto polyimide, and other suitable materials can be used. In someembodiments, the flexibility of the elongated probe 326 will vary fromthe proximal end to the distal end. For example, by creating certainportions that have more or less flexibility than others. This may bedone, for example, by modifying wall thickness, adding material (such asthe cladding discussed above), and/or heat treating certain portions ofthe elongated probe 326 and/or supply tube 330. For example, decreasingthe flexibility of elongated probe 326 along the proximal end canimprove the transfer of force from the hand piece to the elongated probeend for better feel and easier tip placement for treatment. Theelongated probe and supply line 330 are may be configured to resilientlybend in use to different degrees along the length at angles approaching120°, with a varying bend radius as small as 5 mm. In some embodiments,the elongated probe 326 will have external markings along the needleshaft indicating the length of needle inserted into the tissue.

In some embodiments, the probe tip 322 does not include a heatingelement, such as the heater described with reference to probe tip 300,since the effective treating portion of the elongated probe 324 (i.e.,the area of the elongated probe where a cooling zone emanates from) iswell laterally displaced from the hub connector 322 and elongated probeproximal junction. Embodiments of the supply tube are further describedbelow and within commonly assigned U.S. Pub. No. 2012/0089211, which isincorporated by reference.

FIGS. 4A-4C illustrate an exemplary method of creating a hole throughthe skin that allows multiple insertions and positioning of a cryoprobetherethrough. In FIG. 4A a cannula or sheath 1902 is disposed over aneedle 1904 having a tissue penetrating distal end 1908. The cannula mayhave a tapered distal portion 1906 to help spread and dilate the skinduring insertion. The needle/sheath assembly is then advanced into andpierces the skin 1910 into the desired target tissue 1912. The innerpathway of the cannula or sheath 1902 may be curved to assist indirecting the flexible needle 1904, or other probe, into a desiredtissue layer coincident with the desired needle path in the tissue. Oncethe needle/sheath assembly has been advanced to a desired location, theneedle 1904 may be proximally retracted and removed from the sheath1902. The sheath now may be used as an easy way of introducing acryoprobe through the skin without piercing it, and directing thecryoprobe to the desired target treatment area. FIG. 4B shows the sheath1902 in position with the needle 1904 removed. FIG. 4C shows insertionof a cryoprobe 1914 into the sheath such that a blunt tip 1916 of thecryoprobe 1914 is adjacent the target treatment tissue. The cryoprobemay then be cooled and the treatment tissue cooled to achieve any of thecosmetic or therapeutic effects discussed above. In this embodiment, thecryoprobe preferably has a blunt tip 1916 in order to minimize tissuetrauma. In other embodiments, the tip may be sharp and be adapted topenetrate tissue, or it may be round and spherical. The cryoprobe 1914may then be at least partially retracted from the sheath 1902 and/orrotated and then re-advanced to the same or different depth andrepositioned in sheath 1902 so that the tip engages a different portionof the target treatment tissue without requiring an addition piercing ofthe skin. The probe angle relative to the tissue may also be adjusted,and the cryoprobe may be advanced and retracted multiple times throughthe sheath so that the entire target tissue is cryogenically treated.

While the embodiment of FIGS. 4A-4C illustrate a cryoprobe having only asingle probe, the cryoprobe may have an array of probes. Any of thecryoprobes described above may be used with an appropriately sizedsheath. In some embodiments, the cryoprobe comprises a linear or twodimensional array of probes. Lidocaine or other local anesthetics may beused during insertion of the sheath or cryoprobe in order to minimizepatient discomfort. The angle of insertion for the sheath may beanywhere from 0 to 180 degrees relative to the skin surface, and inspecific embodiments is 15 to 45 degrees. The sheath may be inserted anydepth, but in specific embodiments of treating lines/wrinkles of theface, the sheath may be inserted to a depth of 1 mm to 10 mm, and morepreferably to a depth of 2 mm to 5 mm.

In an alternative embodiment seen in FIG. 4D, the sheath 1902 mayinclude an annular flange 1902 b on an outside surface of the sheath inorder to serve as a stop so that the sheath is only inserted a presetamount into the tissue. The position of the flange 1902 b may beadjustable or fixed. The proximal end of the sheath in this embodiment,or any of the other sheath embodiments may also include a one way valvesuch as a hemostasis valve to prevent backflow of blood or other fluidsthat may exit the sheath. The sheath may also insulate a portion of thecryoprobe and prevent or minimize cooling of unwanted regions of tissue.

Any of the cryoprobes described above may be used with the sheathembodiment described above (e.g., in FIG. 3B and FIGS. 4A-4C). Othercryoprobes may also be used with this sheath embodiment, or they may beused alone, in multi-probe arrays, or combined with other treatments.For example, a portion of the cryoprobe 2006 may be insulated as seen inFIG. 5. Cryoprobe 2006 includes a blunt tip 2004 with an insulatedsection 2008 of the probe. Thus, when the cryoprobe is disposed in thetreatment tissue under the skin 2002 and cooled, the cryoprobepreferentially creates a cooling zone along one side while the otherside remains uncooled, or only experiences limited cooling. For example,in FIG. 5, the cooling zone 2010 is limited to a region below thecryoprobe 2006, while the region above the cryoprobe and below the skin2002 remain unaffected by the cooling.

Different zones of cryotherapy may also be created by differentgeometries of the coolant fluid supply tube that is disposed in thecryoprobe. FIGS. 6-9 illustrate exemplary embodiments of differentcoolant fluid supply tubes. In FIG. 6 the coolant fluid supply tube 2106is offset from the central axis of a cryoprobe 2102 having a blunt tip2104. Additionally, the coolant fluid supply tube 2106 includes severalexit ports for the coolant including circular ports 2110, 2112 near thedistal end of the coolant fluid supply tube and an elliptical port 2108proximal of the other ports. These ports may be arranged in varyingsizes, and varying geometries in order to control the flow of cryofluidwhich in turn controls probe cooling of the target tissue. FIG. 7illustrates an alternative embodiment of a coolant fluid supply tube2202 having a plurality of circular ports 2204 for controlling cryofluidflow. FIG. 8 illustrates yet another embodiment of a coolant fluidsupply tube 2302 having a plurality of elliptical holes, and FIG. 9shows still another embodiment of a coolant fluid supply tube 2402having a plurality of ports ranging from smaller diameter circular holes2404 near the distal end of the supply tube 2402 to larger diametercircular holes 2406 that are more proximally located on the supply tube.

As discussed above, it may be preferable to have a blunt tip on thedistal end of the cryoprobe in order to minimize tissue trauma. Theblunt tip may be formed by rounding off the distal end of the probe, ora bladder or balloon 2506 may be placed on the distal portion of theprobe 2504 as seen in FIG. 10. A filling tube or inflation lumen 2502may be integral with or separate from the cryoprobe 2504, and may beused to deliver fluid to the balloon to fill the balloon 2506 up to formthe atraumatic tip.

In some instances, it may be desirable to provide expandable cryoprobesthat can treat different target tissues or accommodate differentanatomies. For example, in FIGS. 11 and 12, a pair of cryoprobes 2606with blunt tips 2604 may be delivered in parallel with one another andin a low profile through a sheath 2602 to the treatment area. Oncedelivered, the probes may be actuated to separate the tips 2604 from oneanother, thereby increasing the cooling zone. After the cryotherapy hasbeen administered, the probes may be collapsed back into their lowprofile configuration, and retracted from the sheath.

In some embodiments, the probe may have a sharp tissue piercing distaltip, and in other embodiments, the probe may have a blunt tip forminimizing tissue trauma. To navigate through tissue, it may bedesirable to have a certain column strength for the probe in order toavoid bending, buckling or splaying, especially when the probe comprisestwo or more probes in an array. One exemplary embodiment may utilize avariable stiff portion of a sleeve along the probe body to provideadditional column strength for pushing the probe through tissue.

In many methods, the temporal branch of the facial nerve which feeds thefrontalis, corrugator supercilii, and other facial muscles, the angularnerve, which enervates the corrugator supercilii and the procerusmuscle, or nerves that enervate other facial muscles can be temporarilydisrupted by applying cold therapy in anatomically based patterns in thetemporal and other regions of the face. The disruption can be performedby using a cryoprobe that decreases the local environmental temperaturesufficiently cold to induce a nerve block. The procedure can be designedto minimize patient discomfort through use of local anesthetics. Alsothe procedure can be performed simply with minimal discomfort and ashort procedure time by targeting the treatment location withappropriate anatomical landmarks and designing the cryoprobe andcryotherapy to provide optimum treatment in minimum time.

In many embodiments, muscle contraction or pain can be eliminated byusing a cryoprobe such as those previously described above to treat thenerve by identifying anatomical landmarks, measuring or applying apredetermined template to/from or between the identified landmarks, andlaterally inserting a cryoprobe, bluntly dissecting tissue using thecryoprobe to reach the desired treatment location in a pattern thatcauses a sufficient number of local facial nerve branches in the targetarea to be impacted by the cryotreatment.

In some embodiments, a method comprises disruption the conduction amotor nerve in order to minimize the appearance of hyperdynamic facialwrinkles in the forehead, frown, crow's feet and other areas of theface. Three examples of diagonal, vertical, and horizontal treatments,respectively, portions A, B, and C, lying across portions of thetemporal branch of a facial nerve (TB-FN) are illustrated in FIG. 13A.The treatment of horizontal forehead wrinkles may be initiated bycreating an incision point beyond the hair line, marked as X, here shownas points A′, B′and C′. In this manner, any temporary scarring caused byexposure to cold or otherwise is hidden from view. The cryogenic needleprobe array is then inserted into the tissue. In some embodiments, asheath can be used as shown in FIGS. 4A-4C, however this is notrequired. Generally, the incision point is laterally displaced from thearea of treatment, with respect to the surface of the skin. In terms oflandmarks, the incision point is generally at the scalp in a regioncovered by hair, i.e., beyond the hairline (e.g., 1-10 mm), in somecases well beyond the hairline (e.g., >10 mm), while the treatment areais underneath a visible portion of the skin.

In some embodiments, the cryogenic probe can be inserted through theskin after an incision is made and then advanced through softer tissuelayers such as fat, muscle or other soft tissue, until a resilienttissue layer or structure is encountered, for example, such as a fasciallayer, cartilage, periosteum, or bone. The resilient nature of thetissue layer prevents puncture by a blunt instrument, such as thecryogenic probe. The tip of the probe can interface with force againstthe resilient tissue layer, and then flex along the resilient tissuelayer without piercing, and be advanced there along in a glidingmovement until its distal tip is in close proximity to a target nervefound in close proximity to a tough protective structure. The nerve canthen be cryogenically treated to create a cosmetically beneficial effectsuch as the alleviation of wrinkles or to mitigate pain in the case of asensory nerve.

Skin tissue, including facial tissue, includes many layers. Insimplistic terms, between skin and muscle lies a layer of subcutaneoustissue, a layer of temporoparietal fascia (TPF), loose areolar tissue,and then deep temporoparietal fascia (sDTF). For the purposes of thisdisclosure, tissue layers between the subcutaneous tissue and musclewill be referred to as the TPF-sDTF layer, or simply TPF-sDTF. Nerves ofinterest for treatment are generally positioned within the TPF-sDTF,and/or directly adjacent, i.e., between the TPF-sDTF and subcutaneoustissue depending on the specific location of the nerve. For example, theTB-FN extends along a portion of the TPF-sDTF layer. The point ofincision is generally made so that the TPF-sDTF is accessible.

With attention back to FIG. 13A, after an incision is made, a cryogenicprobe in inserted into the point of incision, to the depth of theTPF-sDTF, but not past the sDTF. The cryogenic probe includes a distaltip extending from an elongated body. For example, the cryogenic probetip disclosed in FIGS. 3C and 3D can be used. After insertion, the TPFis then bluntly dissected by applying physical force to the cryogenicprobe, to move the elongated body along treatment vectors, shown here asdotted lines. Often, movement of the elongated body is visibleunderneath the skin, thereby enabling positioning of the treatingportion to a particular area. It should be understood that the blunt tipand flexibility of the cryogenic probe enable it to dissect the TPFwhile gliding over the sDTF within the TPF-sDTF layer. This is both asafety and ease-of-use advantage, since piercing the sDTF is veryunlikely due to the blunt tip. Accordingly, the portion of the elongatedprobe body within the TPF-sDTF self-aligns to be substantially parallelto the TPF-sDTF, since it is physically confined between the sDTF andthe upper subcutaneous tissue. Placement of the blunt tip can be aidedby external palpation to encourage the tip to dissect along convex orconcave surfaces and remain within the desired tissue layer.

The cryogenic probe dissects the TPF until a treating portion of thecryogenic probe is directly adjacent to a treatment portion (e.g., A, B,and C) of a target nerve, such as the TB-FN, as illustrated in FIG. 13B.The treating portion of the cryogenic probe is a distinct portion alongthe elongated body where a cooling zone emanates from, typically theexit point(s) of an internal supply tube. In some embodiments the distaltip is the treating portion of the cryogenic probe, while in otherembodiments a mid-portion of the elongated body is the treating portion.As shown, a downward force is applied to the handle of the cryogen probeto longitudinally move the elongated body within the TPF-sDTF. This ispossible due to the self-aligning tendency of the probe within theTPF-sDTF. Thus, the downward force results in forward movement along thelongitudinal axis of the elongated body. When applying the downwardforce, the elongated body can be bent without rupturing the elongatedbody or supply tube, due to the resilient nature of the probe.

Once the cryogenic probe is positioned, it may be activated to generatea cooling zone by flowing a cryogenic fluid through the elongated body,as well described above. The cryogenic probe is held in place until thedesired treatment at the treatment zone is achieved. The cryogenic probecan then be removed from the body, or repositioned for additionaltreatment as further discussed below. Such methods are advantageousbecause they help mitigate visible temporary scaring (i.e., redness,scabs, blackening) that may occur with use of cryogenic needles, sincethe point of incision can be hidden by hair. Also, often only one pointof entry is required, thus greatly reducing the quantity of anytemporary scars. Further, the method mitigates issues associated withnerve depth variability, which can be the case when approaching fromdirectly above the treatment portion with a piercing cryogenic needle,since the target nerve is within the TPF-sDTF that the elongated bodytravels within.

As mentioned above, it may be desirable to create more than onetreatment zone to affect a nerve or cluster of nerves as depicted inFIGS. 13C and 13D. In FIG. 13C, a plurality of treatment zones have beencreated along treatments portions A and C to create a treatment “fence”.This may be achieved by linearly withdrawing or advancing the cryogenicprobe after a treatment is first performed, and then repeating thetreatment at the new location. As shown, three treatment zones have beencreated along treatment portion A, and two treatments zones have beencreated along treatment portion C, however, more treatment zones thanshown can be created. The treatment zones may be spatially separated bysome desired distance, lay end-to-end, or overlap.

An alternative treatment pattern is depicted in FIG. 13D. Here, thecryoprobe has been adjusted angularly about the incision point after aninitial treatment zone has been created, and then used for retreatment,thus creating a treatment “plane”. Generally at least two treatmentzones are required to create a plane, and more may be generated as well.As shown, treatment plane has been created at treatment portions A and Cby performing a plurality of angularly separated treatments at eachportion. As with respect to the method shown in FIG. 13C, treatmentzones for creating a treatment plane may be spatially separated by somedesired distance, lay side-by-side, or overlap. In some embodiments, thecryoprobe is actuatable, such as the probes shown in FIGS. 11 and 12,and thus actuation of the probes can be performed instead of angulardisplacement.

While the exemplary embodiments have been described in some detail forclarity of understanding and by way of example, a number ofmodifications, changes, and adaptations may be implemented and/or willbe obvious to those as skilled in the art. For example, while treatmentof a motor nerve is demonstrated in FIGS. 13C and 13D, the exemplarymethods and devices disclosed herein are also useable in treating anynerve including peripheral nerves which will include sensory nerves.

Further, treatment is not limited to facial tissue, since the interfacesseparating two tissues (e.g. bone, muscle, and organ) including fascialayers are found throughout the body and can be used to guide treatmentof target nerves. Devices and method for pain management are disclosedherein as Appendix A, which consists of U.S. Provisional Application No.61/800,478, which is incorporated by reference. Thus, the devicesdisclosed herein, such as the one shown in FIGS. 3C and 3D, can be usedto treat sensory nerves disclosed in Appendix A. For example, the deviceof FIGS. 3C and 3D can be used to dissect fascia along the first and/orsecond lines of the treatment zone depicted in FIG. 6 of Appendix A, andthus treat sensory nerves that intersect with the treatment zone.

Further, the devices, systems, and methods can be used for management ofmovement disorders, for example such as: Akathisia, Akinesia AssociatedMovements (Mirror Movements or Homolateral Synkinesis), Athetosis(contorted torsion or twisting), Ataxia (gross lack of coordination ofmuscle movements), Ballismus (violent involuntary rapid and irregularmovements), Hemiballismus (affecting only one side of the body),Bradykinesia (slow movement), Cerebral palsy, Chorea (rapid, involuntarymovement), Sydenham's chorea, Rheumatic chorea, Huntington's disease,Dystonia (sustained torsion), Dystonia muscularum, Blepharospasm,Writer's cramp, Spasmodic torticollis (twisting of head and neck),Dopamine-responsive dystonia (hereditary progressive dystonia withdiurnal fluctuation or Segawa's disease), Geniospasm (episodicinvoluntary up and down movements of the chin and lower lip), Myoclonus(brief, involuntary twitching of a muscle or a group of muscles),Metabolic General Unwellness Movement Syndrome (MGUMS), Mirror movementdisorder (involuntary movements on one side of the body mirroringvoluntary movements of the other side), Parkinson's disease, Paroxysmalkinesigenic dyskinesia, Restless Legs Syndrome RLS (WittMaack-Ekbomsdisease), Spasms (contractions), Stereotypic movement disorder,Stereotypy (repetition), Tardive dyskinesia, Tic disorders (involuntary,compulsive, repetitive, stereotyped), Tourette's syndrome, Tremor(oscillations), and Wilson's disease. It is believed that treatment ofnerves associated with such movement disorders using the methods andsystems disclosed herein can be beneficial. Hence, the scope of thepresent invention is limited solely by the independent claims.

1. A method for cryogenically treating a target nerve of a patient, themethod comprising: creating an access site within tissue, the tissuecomprising a temporoparietal fascia-deep temporoparietal fascia layer(TPF-sDTF) beneath skin and a temporal branch of a target nerveextending along a portion of the TPF-sDTF, the access site beinglaterally displaced from the target nerve; inserting a cryogenic probehaving a blunt distal tip extending from an elongated body into theaccess site; bluntly dissecting the TPF while moving the cryogenic probeover the sDTF to position a treating portion of the cryogenic probe at afirst location adjacent to the target nerve; and activating thecryogenic treating portion to create a first treatment zone at the firstlocation to cause a therapeutic effect in the target nerve.
 2. Themethod of claim 1, wherein moving further comprises advancing thecryogenic probe such that the elongated body laterally traverses alongthe sDTF to position the cryogenic treating portion.
 3. The method ofclaim 2, wherein the cryogenic probe includes a supply tube extendingwithin the elongated body from a proximal end of the elongated body tothe cryogenic treating portion, wherein the elongated body and supplytube are configured to resiliently bend.
 4. The method of claim 2,further comprising deflecting the blunt distal tip of the cryogenicprobe against the sDTF.
 5. The method of claim 2, further comprisingbending a portion of the elongated body of the cryogenic probe prior toinserting the cryogenic probe into the access site.
 6. The method ofclaim 2, wherein a portion of the elongated body is configured toself-align within the TPF to be substantially parallel with the sDTF asit laterally traverses along the sDTF.
 7. The method of claim 1, furthercomprising relocating the treating portion of the cryogenic probe to asecond treatment location, and activating the cryogenic probe to createa second treatment zone at the second location to further thetherapeutic effect.
 8. The method of claim 7, wherein the secondtreatment zone is adjacent to the first treatment zone or overlaps withthe first treatment zone.
 9. The method of claim 1, wherein the targetnerve is the temporal branch of a facial nerve.
 10. The method of claim1, wherein the target nerve is a sensory nerve.
 11. A method forcryogenically treating a nerve of a patient, the method comprising:creating an access site within tissue laterally displaced from a nerve,the tissue comprising skin, a layer of soft tissue and a layer ofresilient tissue; inserting a cryogenic probe having a cryogenictreating portion and a blunt distal tip extending from an elongated bodyinto the access site; bluntly dissecting the layer of soft tissue usingthe cryogenic probe such that the cryogenic treating portion of thecryogenic probe is directly adjacent to the layer of resilient tissue;advancing the cryogenic probe along the layer of resilient tissue toposition the treating portion of the cryogenic probe at a first locationadjacent to the nerve; and repeatedly moving and activating thecryogenic treating portion to generate a plurality treatment zonesacross the nerve adjacent to the layer of the resilient tissue to causea therapeutic effect in the nerve.
 12. The method of claim 11, whereinadvancing further comprises laterally traversing the elongated body ofthe cryogenic probe along the layer of resilient tissue to position thecryogenic treating portion at the first location adjacent to the nerve.13. The method of claim 12, wherein the cryogenic probe includes asupply tube extending within the elongated body from a proximal end ofthe elongated body to the cryogenic treating portion, wherein theelongated body and supply tube are configured to resiliently bend. 14.The method of claim 12, further comprising deflecting the blunt distaltip of the cryogenic probe against the layer of resilient tissue. 15.The method of claim 11, wherein the layer of soft tissue is comprised ofadipose tissue, subcutaneous tissue, and/or muscle.
 16. The method ofclaim 11, wherein the layer of resilient tissue is fascia, cartilage,periosteum, or bone.
 17. The method of claim 11, wherein the tissuecomprises muscle under the layer of resilient tissue and wherein thelayer of resilient tissue comprises a tissue interface separating themuscle and the layer of soft tissue.
 18. The method of claim 11, whereinthe nerve is a sensor nerve or motor nerve.
 19. The method of claim 11,wherein moving comprises linearly withdrawing or advancing the cryogenicprobe along the layer of resilient tissue.
 20. The method of claim 11,wherein each treatment zone of the plurality of treatment zones isspatially separated from each other.
 21. The method of claim 11, whereineach treatment zone of the plurality of treatment zones overlaps withone another.
 22. The method of claim 11, wherein the treatment zonescomprise a treatment fence or plane across the nerve.